Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function

NCT ID: NCT06004687

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2024-12-30

Brief Summary

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Patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and postoperative cognitive dysfunction due to greater trauma and longer operation time. Pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general anesthesia and postoperative cognitive function. Intravenous injection of non-steroidal drugs can effectively reduce postoperative pain and the use of opioids. Therefore, This study selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on anesthesia recovery time and postoperative cognitive function of patients undergoing gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in patients undergoing gastrointestinal tumor surgery

Detailed Description

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By administering acetaminophen to patients with gastrointestinal tumors before surgery, recording the time to recovery from anesthesia, and assessing cognitive function status by CAM on the first, third, and seventh day after surgery

Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery

Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery

Group Type ACTIVE_COMPARATOR

acetaminophen mannitol

Intervention Type DRUG

Intravenous acetaminophen was administered 30 minutes before anesthesia

By applying normal saline to patients with gastrointestinal tumors before surgery

Normal saline injection 50ml intravenously pumped 30 minutes before surgery

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Intravenous acetaminophen was administered 30 minutes before anesthesia

Interventions

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acetaminophen mannitol

Intravenous acetaminophen was administered 30 minutes before anesthesia

Intervention Type DRUG

Normal saline

Intravenous acetaminophen was administered 30 minutes before anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing gastrointestinal tumor surgery
* American Society of Anesthesiologists(ASA)≤Ⅲ

Exclusion Criteria

* History of severe adverse reactions to oral acetaminophen
* Dysfunction of heart, liver, kidney and other important organs
* History of chronic pain
* Oral non-steroidal or opioid drugs
* Patients who do not accept clinical trials
Minimum Eligible Age

16 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongsheng Chen

Role: STUDY_CHAIR

Chair

Locations

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Affiliated Hospital of nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongsheng Chen

Role: CONTACT

+86 513 81160313

Chaochao Zhong

Role: CONTACT

+86 513 81160313

Facility Contacts

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Hongsheng Chen

Role: primary

+86 513 8116 0313

Other Identifiers

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zhhszjjh

Identifier Type: -

Identifier Source: org_study_id

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